Clinical Trial Results:
A prospective phase II study on dose escalation using PET based adaptive IMRT stage II-III non small lung cancer
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Summary
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EudraCT number |
2011-003124-12 |
Trial protocol |
BE |
Global end of trial date |
28 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Mar 2023
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First version publication date |
20 Mar 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B-40320109424
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cliniques Universitaires Saint Luc
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Sponsor organisation address |
Avenue Hippocrate, 10, Bruxelles, Belgium, 1200
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Public contact |
GEETS, Xavier, Cliniques Universitaires Saint Luc, xavier.geets@saintluc.uclouvain.be
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Scientific contact |
GEETS, Xavier, Cliniques Universitaires Saint Luc, xavier.geets@saintluc.uclouvain.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To assess the impact of individualized and escalated dose prescription based on FDG-PET on the tumor local control, the local progression-free survival and overall survival.
• To secondarily assess early and late radio-induced toxicities
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Protection of trial subjects |
Not specified
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2010
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Scientific research | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients enrolled from Novembre 2010 till February 2013, at the Belgian hospitals Inclusion: - Patients with histolagically proven stage II-III NSCLC - FDG-PET positive primary tumor > 3 cm - Patient considered fit for sequential or concomitant CRT (i.e. ECOG performance status < or =2) | ||||||||||||||||
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Pre-assignment
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Screening details |
Exclusion: - No Bulky lymph node (LN) involvement (==> average LN diameter of 13.3 +/- 5.5 mm) - Prior thoracic radiation - Poor lung | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
Not applicable
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Arms
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Arm title
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Radiotherapy | ||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
18F fluorodeoxyglucose
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
18F fluorodeoxyglucose was administred as per standard of care.
The dose prescription for Radiotherapy :
o The treatment total dose (TTD) will be based on normal tissue constraints instead of a classic fixed prescribed dose. Actually, the radiation dose will be individually escalated until a dose-limiting normal tissue constraint is reached.
o The radiation treatment will begin at day 22 of chemotherapy (corresponding to the first day of the cycle 2 chemotherapy) based on cisplatin/etoposide or cisplatin/vinorelbine regimens.
o Prescribed dose on PTV1 : 25x2.3Gy once daily
o Prescribed dose on PTV2: dose escalation with Simultaneous Integrated Boost (SIB) based on the tolerance of the organs at risk (OARs) until a maximal dose per fraction of 3Gy once daily,
corresponding to a maximal total dose of 75Gy (physical dose).
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
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End points reporting groups
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Reporting group title |
Radiotherapy
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Reporting group description |
- | ||
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End point title |
Overall survival - at 36 month [1] | ||||
End point description |
Survival was determined using the Kaplan-Meier method, the results were presented with median and CI at 95% - there were 7 patients who were still alive after followup.
The result of the overall survival with Kaplan-Meier estimate (in months) was NE with IC95% (13.85 - NE).
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End point type |
Primary
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End point timeframe |
Entire study - follow-up included
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Kaplan Meier was performed - however, as some patients survived after follow-up, some results are showing "NE" as the number of survival months is not evaluable. And EudraCT doesn't allow to add "NE" instead of a number. |
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| No statistical analyses for this end point | |||||
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Adverse events information
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Timeframe for reporting adverse events |
Overall study
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
ICD 10 - English | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2010
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Reporting groups
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Reporting group title |
Experimental
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/28733723 |
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